Apparatus and methods for alignment and deployment of intracardiac devices

ABSTRACT

Apparatus and methods are described herein for use in the alignment and deployment of a prosthetic heart valve, such as a mitral valve. In some embodiments, an apparatus includes a tube assembly and a needle assembly configured to be received through a lumen of an outer tube member of the tube assembly. The needle assembly includes an elongate needle having a distal tip configured to be inserted through the epicardial surface of a heart. An imaging probe is coupled to a coupling member and includes an imaging element. The imaging probe is configured to provide image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of the mitral valve and the annular region of the heart such that a prosthetic mitral valve can be positioned within the heart based at least in part on the C-C plane and the A-P plane.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No. 15/085,229, filed Mar. 30, 2016, which is a continuation under 35 USC § 120 of International Application No. PCT/US2014/061046, filed Oct. 17, 2014, entitled “Apparatus and Methods for Alignment and Deployment of Intracardiac Devices,” which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/892,390, filed Oct. 17, 2013, entitled “Apical ICE Echo Probe,” each of the disclosures of which is incorporated herein by reference in its entirety.

BACKGROUND

Embodiments are described herein that relate to devices and methods for use in the deployment and alignment of a medical device such as an intracardiac device.

When deploying a prosthetic mitral valve, it is important that the valve is seated within the native annulus (for valves that do not require excision of the native valve) in such a manner as to avoid hemodynamic leakage. Leaking can occur where the prosthetic valve meets the commissures, meets the anterior leaflets, and/or meets the posterior leaflets. Accordingly, some newer generation valves are equipped with a flange or cuff that is atrially seated, maintains patency during its lifetime, and funnels cardiac atrial output through a one-way valve and into the ventricle. Accordingly, proper alignment of the annular seal is critical to the effectiveness of the valve and to the life of the patient. Thus, devices for aligning the transventricular tether of such a valve would be considered useful to solve these and other problems known in the art.

SUMMARY

Apparatus and methods are described herein for use in the alignment and deployment of a transcatheter prosthetic valve, such as a prosthetic mitral valve. In some embodiments, an apparatus includes an outer tube member defining a lumen and a needle assembly configured to be received through the lumen of the outer tube member. The needle assembly includes an elongate needle having a distal tip configured to be inserted through the epicardial surface of a heart and extend within the left ventricle of the heart. An imaging probe is coupled to the needle assembly and includes a cable and an imaging element disposed at a distal end portion of the cable. The imaging probe is configured to provide image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of the mitral valve and the annular region of the heart such that a prosthetic mitral valve can be positioned within the heart based at least in part on the C-C plane and the A-P plane.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a cross-sectional illustration of portion of a heart with a prosthetic mitral valve implanted therein and an epicardial anchor device anchoring the mitral valve in position.

FIG. 2A is a schematic illustration of an alignment device, according to an embodiment.

FIG. 2B is a schematic illustration of the alignment device of FIG. 2A shown positioned near an epicardial surface of a heart.

FIG. 3 is a perspective view of an alignment device, according to another embodiment.

FIG. 4 is another perspective view of the alignment device of FIG. 3.

FIG. 5A is a cross-sectional illustration of a portion of a heart with a prosthetic mitral valve deployed into the mitral annulus and having an anchoring tether extending through the ventricle and anchored to the epicardial surface of heart with an epicardial pad device.

FIG. 5B illustrates the commissural-commissural (C-C) plane and the anterior-posterior (A-P) plane of a mitral valve and annular region of a heart with a tether extending therebetween.

FIGS. 6A-6D are schematic illustrations showing various views of the prosthetic mitral valve and tether of FIG. 5A deployed within a heart.

FIG. 7 is a schematic illustration showing a line of sight between the commissural-commissural (C-C) plane and the anterior-posterior (A-P) plane of the mitral valve and tether of FIGS. 6A-6D deployed within the heart.

FIG. 8 is a plan view of an alignment device, according to another embodiment.

FIG. 9 is a perspective view of a portion of the alignment device of FIG. 8.

FIG. 10 is a perspective view of a needle assembly of the alignment device of FIG. 8.

FIG. 11 is a side view of the needle assembly disassembled and the tube assembly of the alignment device of FIG. 8.

FIG. 12 is an enlarged perspective view of a portion of the alignment device of FIG. 8 showing the cable and imaging element coupled to the imaging element mounting member.

FIG. 13 is a flowchart illustrating a method of deploying and aligning a prosthetic mitral valve, according to an embodiment.

FIG. 14 is a flowchart illustrating another method of deploying and aligning a prosthetic mitral valve, according to an embodiment.

FIG. 15 is a schematic illustration of a mitral valve deployment and alignment kit, according to an embodiment.

FIGS. 16 and 17 are each a screen shot of an ultrasound image of a heart showing an alignment path projected onto the image.

DETAILED DESCRIPTION

Apparatus and methods are described herein for use in the alignment and deployment of a transcatheter prosthetic valve, such as a prosthetic mitral valve. As described herein, an alignment device that includes an imaging probe can be used to determine a location and orientation for positioning a tether coupled to a prosthetic mitral valve and securing the tether with an epicardial pad at the epicardial surface of a heart.

In some embodiments, an alignment device includes a handheld intracardiac echocardiography (ICE) probe coupled to a percutaneous transmyocardial needle/tube component. The ICE probe can include a control wand connected to an imaging element with a cable. The imaging element includes a side-looking multi-element phased array transducer with multi-way steerability. The imaging probe can include a distal targeting loop for epicardial surface contact. The distal targeting loop can define an aperture and the percutaneous transmyocardial needle/tube component can be configured to travel along a longitudinal axis through the aperture. The alignment device is configured to facilitate alignment of the longitudinal axis of the percutaneous transmyocardial needle/tube component.

In some embodiments, the imaging probe is an 8 or 10 French probe. In some embodiments, the imaging element (e.g., transducer) can operate at a frequency ranging from about 5.0 to about 8.5 MHz. In some embodiments, the imaging probe is configured to provide greyscale imaging, color Doppler imaging, tissue imaging, and/or 3D localization.

In some embodiments, a method for aligning a prosthetic heart valve for deployment within a native mitral valve can include using an alignment device as described herein to identify the commissural-commissural (C-C) plane or axis and the anterior-posterior (A-P) plane or axis of the mitral valve and annular region. In some embodiments, the method can further include deploying an asymmetric compressed self-expanding transcatheter valve to the mitral annulus. The method further can further include orienting the asymmetric compressed self-expanding transcatheter valve to minimize left ventricular outflow tract (LVOT) obstruction.

In some embodiments, a surgical kit can include an alignment device as described herein and a transcatheter prosthetic valve delivery device both disposed within a sterile package. In some embodiments, a kit can further include a transcatheter valve (e.g., a prosthetic mitral valve) and/or an epicardial pad that can be used to secure the transcatheter valve in position within the heart.

As used herein, the words “proximal” and “distal” refer to a direction closer to and away from, respectively, an operator of, for example, a medical device. Thus, for example, the end of the medical device closest to the patient's body (e.g., contacting the patient's body or disposed within the patient's body) would be the distal end of the medical device, while the end opposite the distal end and closest to, for example, the user (or hand of the user) of the medical device, would be the proximal end of the medical device.

In some embodiments, an alignment device is described herein that can be used in conjunction with a procedure to deliver and anchor a compressible prosthetic heart valve replacement (e.g., a prosthetic mitral valve), which can be deployed into a closed beating heart using a transcatheter delivery system. An epicardial pad device or system can be used to anchor such a prosthetic heart valve replacement. Such an epicardial pad system can be deployed via a minimally invasive procedure such as, for example, a procedure utilizing the intercostal or subxyphoid space for valve introduction. In such a procedure, the prosthetic valve can be formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the target location, for example, the mitral or tricuspid valve annulus.

A compressible prosthetic mitral valve can have a shape, for example that features a tubular stent body that contains leaflets and an atrial cuff. This allows the valve to seat within the native mitral annulus. The use of a flexible valve attached using an apical tether can provide compliance with the motion and geometry of the heart. The geometry and motion of the heart are well-known as exhibiting a complicated biphasic left ventricular deformation with muscle thickening and a sequential twisting motion. The additional use of the apically secured ventricular tether helps maintain the prosthetic valve's annular position without allowing the valve to migrate, while providing enough tension between the cuff and the atrial trabeculations to reduce, and preferably eliminate, perivalvular leaking. The use of a compliant valve prosthesis and the special shape and features can help reduce or eliminate clotting and hemodynamic issues, including left ventricular outflow tract (LVOT) interference problems. Many known valves are not able to address problems with blood flow and aorta/aortic valve compression issues.

Structurally, the prosthetic heart valve can include, for example, a self-expanding tubular frame having a cuff at one end (the atrial end), one or more attachment points to which one or more tethers can be attached, preferably at or near the ventricular end of the valve, and a leaflet assembly that contains the valve leaflets, which can be formed from stabilized tissue or other suitable biological or synthetic material. In one embodiment, the leaflet assembly may include a wire form where a formed wire structure is used in conjunction with stabilized tissue to create a leaflet support structure, which can have anywhere from 1, 2, 3 or 4 leaflets, or valve cusps disposed therein. In another embodiment, the leaflet assembly can be wireless and use only the stabilized tissue and stent body to provide the leaflet support structure, and which can also have anywhere from 1, 2, 3 or 4 leaflets, or valve cusps disposed therein.

The upper cuff portion may be formed by heat-forming a portion of a tubular nitinol structure (formed from, for example, braided wire or a laser-cut tube) such that the lower portion retains the tubular shape but the upper portion is opened out of the tubular shape and expanded to create a widened collar structure that may be shaped in a variety of functional regular or irregular funnel-like or collar-like shapes.

A prosthetic mitral valve can be anchored to the heart at a location external to the heart via one or more tethers coupled to an anchor device, as described herein. For example, the tether(s) can be coupled to the prosthetic mitral valve and extend out of the heart and be secured at an exterior location (e.g., the epicardial surface) with an anchor device, as described herein. An anchor device can be used with one or more such tethers in other surgical situations where such a tether may be desired to extend from an intraluminal cavity to an external anchoring site.

FIG. 1 is a cross-sectional illustration of the left ventricle LV and left atrium LA of a heart having a transcatheter prosthetic mitral valve PMV deployed therein and an epicardial anchor device EAD securing the prosthetic mitral valve PMV in place. FIG. 1 illustrates the prosthetic mitral valve PMV seated into the native valve annulus NA and held there using an atrial cuff AC of the prosthetic mitral valve PMV, the radial tension from the native leaflets, and a ventricular tether T secured with attachment portions Tp to the prosthetic mitral valve PMV and to the epicardial anchor EAD. The apparatus and methods described herein can be used in conjunction with the various different types and embodiments of an epicardial anchor device, such as those described in pending International Patent Application No. PCT/2014/049218 entitled “Epicardial Anchor Devices and Methods,” (“PCT application '049218”) the disclosure of which is incorporated herein by reference in its entirety.

FIG. 2A is a schematic illustration of an alignment device, according to an embodiment. An alignment device 100 includes a needle assembly 120, a tube assembly 130 and an imaging probe 140. The tube assembly 130 includes an outer tube member 122 and an imaging element coupling member 124 coupled to a distal end portion of the outer tube member 122. The needle assembly 120 is movably received at least partially within a lumen defined by the outer tube member 122. The needle assembly 120 includes a needle tube 126 and an elongate needle 128 that is at least partially movably received through a lumen of the needle tube 126. The elongate needle 128 includes a distal tip or stylet 129 (shown in FIG. 2B) configured to pierce through tissue.

The imaging probe 140 is coupled to the outer tube member 122 and/or the imaging element coupling member 124. The imaging probe 140 includes an elongate cable 132 coupled on a proximal end to a handle assembly 136 and having on a distal end portion an imaging component 134. The distal end portion and imaging element 134 can be coupled to the imaging element coupling member 124 of the tube assembly 130. The cable 132 electrically and operatively couples the imaging element 134 to control components (not shown) included in the handle 136. In some embodiments, the imaging probe 140 can be, for example, an 8 or 10 French Acuson AcuNav™ device that is coupled to the outer tube member 122. The imaging element 134 can include one or more ultrasound transducers. In some embodiments, the imaging element 134 can include a side-looking 64-element phased array transducer with 4-way steerability, can operate at a frequency ranging from about 5.0-8.5 MHz or about 5.0-7.0 MHz, and/or provide greyscale imaging, color doppler imaging, tissue imaging, and/or 3D localization with Cartosound. In other embodiments, the imaging probe can be, for example, a known probe such as the UltraICE device from Boston Scientific, the EP Med View Flex catheter or ClearICE from St. Jude Medical, or the SoundStar from Biosense-Webster, or functionally similar to any one of these example imaging devices. Such a known imaging probe can be coupled to the tube assembly 130 as described above.

The handle 136 can be operatively coupleable to a computer device 138 that includes, for example, a display device (e.g., a computer monitor) such that image data collected by the imaging element 134 can be collected and stored within a memory of the computer device 138 and can be viewed on the display device. In some embodiments, an additional sleeve member (not shown in FIG. 2) is also included. In such an embodiment, a portion of the cable 132 and a portion of the outer tube member 122 can be received within a lumen of the sleeve member as described and shown with reference to the embodiment illustrated in FIGS. 3 and 4.

The alignment device 100 can be used in conjunction with a prosthetic intracardiac delivery device to facilitate the alignment and positioning of an intracardiac device such as, for example, a prosthetic mitral valve. The alignment device 100 can be used to determine a desired or optimal location on the epicardial surface to place an epicardial pad to secure a tether attached to a prosthetic valve as described in more detail below. The alignment device 100 can also be used to provide image data of the heart such that the commissural-commissural (C-C) plane or axis and the apical-posterior (A-P) plane or axis of the mitral valve and the annular region of the heart can be identified. This information can then be used to position and align a prosthetic mitral device in a desired location and orientation as described in more detail below with reference to specific embodiments. Thus, during a procedure, after using the alignment device 100, a prosthetic mitral valve can be deployed within the left atrium of the heart and a tether coupled to the prosthetic mitral valve and extending outside the heart can be aligned and secured at a desired location with an epicardial pad device.

FIG. 2B is a schematic illustration of a portion of the alignment device 100 shown in use to image a heart H. In use, the coupling member 124 is placed near or in contact with the epicardial surface ES of the heart near, for example, the apex of the heart. The imaging element 134 (not shown in FIG. 2B) of the imaging probe 140 can then be used to image the heart to determine an alignment path for a tether attached to the prosthetic valve such that an initial desired location on the apex of the epicardial surface to anchor the tether with an epicardial pad can be determined. For example, images up through the heart can be taken, and the image data can be used to determine an alignment path between the location of the native mitral valve NMV (e.g., a centerline of the mitral valve) and the apex of the heart at the epicardial surface ES. The alignment path can be used to align the tether with the centerline of the native mitral valve and can also be used to guide the needle assembly 120 along the trajectory of the alignment path during a procedure to deploy the prosthetic mitral valve. Using the image data, an optimal or desired location to secure the tether to the epicardial surface can be determined. For example, the optimal location can be substantially perpendicular to the alignment path, which is perpendicular to the C-C plane (described below). Specifically, the imaging probe 140 can produce image data such that the C-C plane and the A-P plane can be identified. For example, alignment device 100 can be placed in a first orientation relative to the heart and first image data can be collected and stored and displayed on the computer device 138. The alignment device 100 can then be rotated, for example, 90 degrees and second image data can be obtained. From this image data, the C-C plane and the A-P plane of the mitral valve and annular region of the heart can be identified. For example, the C-C plane can be identified in the first image data and the A-P plane can be identified in the second image data. For example, the image data can be displayed on a display device of the computer device and a user (e.g., physician) can visually identify the location of the C-C plane/axis and A-P plane/axis. Using the image data produced by the alignment device 100, the user can project an alignment path that is, for example, perpendicular to the C-C plane, and the alignment path can be used to determine the optimal or desired location to secure the tether of a prosthetic mitral valve at the epicardial surface of the heart (e.g., at the apex).

FIGS. 16 and 17 are each an example screenshot of an ultrasound image of the heart that can be produced using the alignment device 100. FIG. 16 is a C-C, mid-esophageal two-chamber view of the heart, produced, for example, with the alignment device positioned at a first orientation relative to the heart. FIG. 17 is an A-P, mid-esophageal long axis view of the heart, produced, for example, with the alignment device 100 positioned at a second orientation relative to the heart 90 degrees from the first orientation. As shown in FIGS. 16 and 17, the C-C plane and the A-P plane can be visually identified and an alignment path 135 can be projected onto the images (e.g., manually by the user) or the user can visually determine an alignment path to use. The alignment path 135 can extend between the C-C plane and the atrioventricular plane of the heart. As shown in FIGS. 16 and 17, the alignment path 135 extends through approximately the center of the native mitral valve NMV. As described above, the alignment path 135 can be used to determine a location to secure a tether of a prosthetic mitral valve to the epicardial surface such that the tether is aligned substantially perpendicular to the C-C plane and the prosthetic mitral valve is perpendicular to the C-C plane.

After the alignment device 100 has been used to obtain the desired image data, and the alignment path (and initial epicardial pad location) and the coordinates for the C-C plane and the A-P plane have been determined, the needle assembly 120 can be moved distally within the outer tube member 122 such that the distal piercing tip 129 of the elongate needle pierces through the epicardial surface at the desired pad location (e.g., determined with the image data described above). The needle assembly 120 can be extended within the left ventricle of the heart along the trajectory of the alignment path. For example, the distal tip 129 of the elongate needle 128 can be disposed distal of the needle tube 126 such that as the needle assembly 120 is moved distally through the outer tube member 122, the distal tip 129 can pierce the epicardial surface and pass through the wall of the heart and within the left ventricle. The elongate needle 128 of the needle assembly 120 can then be removed leaving the needle tube 126 within the heart and extended within the left ventricle. A guidewire (not shown) can then be inserted through the needle tube 126 and positioned within the heart. The needle tube 126 can then be removed from the heart, and the alignment device 100 removed from the patient's body. A prosthetic mitral valve (not shown in FIGS. 2A and 2B) can then be deployed within the atrium using a prosthetic valve delivery device as described in more detail below. The identified C-C plane and A-P plane can then be used to position and align the prosthetic mitral valve and to secure a tether coupled to the prosthetic mitral valve to the epicardial surface using an epicardial pad device.

FIGS. 3 and 4 are each a perspective view of an alignment device 200 according to an embodiment. The alignment device 200 can include the same or similar features and can function the same as or similar to the alignment device 100 and can be used to perform the same or similar procedures as described above for alignment device 100. The alignment device 200 includes a tube assembly 230, a needle assembly 220 and an imaging probe 240. The tube assembly 230 includes an outer tube member 222 and an imaging element coupling member 224 (also referred to herein as “coupling member”) coupled to a distal end of the outer tube member 222. The needle assembly 220 is movably received at least partially within a lumen defined by the outer tube member 222 and includes a needle tube 226 and an elongate needle (not shown in FIGS. 3 and 4) that includes a piercing distal tip or stylet (not shown) and an end cap 256 on a proximal end. As shown in FIGS. 3 and 4, the elongate needle and distal tip are retracted within the needle tube 226 and therefore are not visible. The needle assembly 222 includes a needle coupler 250 that can be used to tighten the needle tube 226 to the elongate needle to control or prevent movement of the elongate needle within the needle tube 226 as desired. For example, the needle coupler 250 can have a threaded attachment such that it can be rotated to tighten or loosen the needle tube 226. The needle coupler 250 can be, for example, a luer type connector. A hemostasis valve 252 is coupled to the outer tube member 222 and can be used to prevent bleeding back through the needle system during a procedure. The tube assembly 230 includes a luer connector 254 that is coupled to the outer tube member 222 and is configured to control or prevent movement of the needle assembly 220 within the outer tube member 222 as desired. The imaging element coupling member 224 defines a hole (not shown) through which the elongate needle and distal piecing tip of the needle assembly 222 can pass through and exit the distal end of the alignment device 200.

The imaging probe 240 includes a cable 232 coupled to a handle assembly 236, and an imaging element 234 coupled to a distal end portion of the cable 232. The imaging probe 240 can be the same as or similar to the imaging probe 140 described above. For example, the imaging probe 240 can be a known imaging probe that can be coupled to the tube assembly 230. Similarly, the cable 232, handle assembly 236, and imaging element 234 can each be the same as or similar to, and can provide the same as or similar function as the cable 132, handle assembly 136, and imaging element 134, respectively, described above. In this embodiment, the imaging probe 240 also includes an outer sheath 241 covering a portion of the cable 232 and a distal end portion of the cable 232 forms a targeting loop 242. In use, the targeting loop 242 is configured to contact the epicardial surface of a heart as described in more detail below. The distal end portion of the targeting loop 242 is coupled to the imaging element coupling member 224 and the imaging element 234 (shown in FIG. 4) is coupled to a distal end portion of the targeting loop 242. A screw 243 or other fastener can be used to secure the cable 232 and the imaging element 234 to the imaging element coupling member 224. In this embodiment, a portion of the cable 232 within the outer sheath 241 and a portion of the outer tube member 222 are disposed within a lumen of an outer sleeve component 244.

As with the previous embodiment, the cable 232 electrically and operatively couples the imaging element 234 to control components (not shown) included in the handle 236. As with the previous embodiment, the handle 236 can be operatively coupleable to a computer device (not shown) as described above. For example, the handle 236 includes a connection portion 246 that can be used to electrically couple the imaging probe 240 to a computer device.

As described above for alignment device 100, alignment device 200 can be used during a procedure to deploy a prosthetic heart device, such as, a prosthetic mitral valve. In use, the targeting loop 242 and imaging element coupling member 224 are placed near or in contact with the epicardial surface of the heart. The imaging element 234 of the imaging probe 240 can then be used to image the heart to determine an alignment path for a tether attached to the prosthetic valve such that an initial desired location on the apex of the epicardial surface to anchor the tether with an epicardial pad can be determined as described above for alignment device 100. The imaging probe 240 can also produce image data such that the C-C plane and the A-P plane can be identified as described above.

Also as described above, after the alignment device 200 has been used to obtain the desired image data, and the alignment path (and initial epicardial pad location) and the coordinates for the C-C plane and the A-P plane have been determined, the needle assembly 220 can be moved distally within the outer tube member 222 such that the distal piercing tip of the elongate needle pierces through the epicardial surface at the desired pad location (e.g., determined with the image data described above), and extends to the left ventricle of the heart. For example, the distal tip of the elongate needle can be disposed distal of the needle tube 226 such that as the needle assembly 220 is moved distally through the outer tube member 222, the distal tip can pierce the epicardial surface and pass through the wall of the heart and within the left ventricle. The elongate needle of the needle assembly 220 can then be removed leaving the needle tube 226 within the heart and extended within the left ventricle. A guidewire (not shown) can then be inserted through the needle tube 226 and positioned within the heart. The needle tube 226 can then be removed from the heart, and the alignment device 200 removed from the patient's body. A prosthetic mitral valve can then be deployed within the atrium using a prosthetic valve delivery device as described in more detail below. In some embodiments, a dilator device (not shown) can be used prior to inserting a delivery device to enlarge the opening at the epicardial surface. The identified C-C plane and A-P plane can then be used to position and align the prosthetic mitral valve and to secure a tether coupled to the prosthetic mitral valve to the epicardial surface using an epicardial pad device.

FIG. 5A illustrates a prosthetic mitral valve 360 deployed within the mitral annulus in an atrium of a heart and an intraventricular tether 362 (also referred to as “tether”) coupled to the prosthetic mitral valve 360 extending through the ventricle exiting an apical aperture and anchored to the epicardial surface with an epicardial pad device 364. In this example, such a prosthetic valve 360 is a compressible self-expanding transcatheter valve and includes a valve lumen 366, a prosthetic valve atrial cuff 368 and a valve body 370. However, it should be understood that the alignment devices described herein can be useful for various other surgical or interventional medical procedures, and particularly for procedures involving the deployment of intracardiac devices. As shown in FIG. 5A, in this example, intraventricular tether 362 is shown as perpendicular to a plane of the epicardial pad device 364 at the point of contact with the epicardial surface, and to the placement of the prosthetic valve.

In procedures involving the deployment of prosthetic mitral valves, having the valve properly seated within the native annulus helps prevent regurgitant leaking. Unlike some known prosthetic valves, a self-expanding prosthetic valve 360 as shown in FIG. 5A does not need to be sewn into place. Historically, in the first generation of artificial valves, such valves were delivered during open heart surgery and the native valve leaflets would be cut away, and a prosthetic valve sewn into place. In such approaches, however, complications can arise from open surgery and sternotomies. Second generation valves were delivered by a cardiac interventionalist, not a surgeon, using a catheter, and required balloon expansion, and were also sewn into place using endoscopic/catheter-based techniques. Third generation valves are characterized by being constructed of self-expanding martensidic/austenitic materials that did not require to be sewn into place. This avoided the problems associated with cardiac remodeling caused by sewing a rigid prosthetic to a dynamic tissue. However, tethering and seating these valves became of utmost importance to avoid leaking during systole.

Proper alignment of prosthetic valves in the C-C commissural plane/axis and the A-P anterior-posterior plane/axis can reduce and/or avoid perivalvular leakage around such prosthetic valves. However, the mitral valve is known to have a highly complex three-dimensional shape, namely a hyperbolic paraboloid, or more commonly, the shape of a well-known stackable potato chip. Another problem concerns LVOT obstruction. Prosthetic valves that apply significant lateral pressure against the anterior portion of the annulus can cause obstruction of the aortic flow exiting the left ventricle because the mitral annulus and the aorta share a common wall at the anterior segment of the mitral valve. The consequence of this is that sealing against perivalvular leaking while avoiding LVOT can be a challenge. Thus, fourth generation devices have implemented an asymmetric design to accommodate the seating of the prosthetic valve into the native annulus, while at the same time eliminating the lateral annular pressure that causes LVOT obstruction. But this raises another issue, namely, that the prosthetic valve, now asymmetric, must be deployed so that the axis of the valve features is in alignment with the axis of the mitral annulus.

Referring now to FIG. 5B, which is a schematic illustration showing the commissural-commissural (C-C) plane/axis, labeled P1, the apical lateral plane/axis, labeled P2, the anterior-posterior plane/axis, labeled P3, and the apical longitudinal plane/axis, labeled P4. As shown, in this example, the plane/axis P1 is substantially parallel to the plane/axis P2 such that tether 362 intersects both the plane/axis P1 and the plane/axis P2 at substantially 90 degree angles. The plane/axis P3 is also shown to be substantially parallel to the plane/axis P4. The angles alpha α (between tether 362 and plane/axis P1), beta β (between tether 362 and P2), gamma γ (between tether 362 and P3), and delta δ (between tether 362 and P4), can vary, for example, according to ranges of 85 to 95 degrees, 80 to 100 degrees, and 75 to 105 degrees. The angle relationship between the planes/axis P1 and the plane/axis P2, and the angle relationship between the plane/axis P3 and the plane/axis P4 can also vary accordingly from being parallel as shown, depending on the particular anatomy encountered with a given patient.

FIGS. 6A-6D illustrate a series of schematic sectional views showing the prosthetic valve and tether deployed within the heart. FIG. 6A shows a prosthetic mitral valve 360 deployed within the mitral annulus in the atrium of the heart and the intraventricular tether 362 extending through the floor/apex 372 of the ventricle. FIG. 6B shows an epicardial view showing the epicardial pad 364 affixed to the apical surface of the heart, and the tether 362 coupled to the pad 364 through the ventricle. FIG. 6C shows a view of the left ventricle showing the bottom of the prosthetic valve body 370 that is deployed in the native annulus, and the tether 362 extending intraventricularly away from valve 360 towards the apex 372 and pad 364. FIG. 6D is an apical view of the heart showing the epicardial pad 364 affixed to the epicardial surface with the tether 362 tied off and trimmed.

FIG. 7 is a cross-sectional side view illustration of the intended final alignment of the deployed valve 360. FIG. 7 shows the ventricular wall in cross-section with a sight-line S with point A-to-point B extending from the ventricular apex 372 along tether 362 towards the atrium and commissural plane/axis P1. The angle, beta δ, near the apex 372 is shown as one of the useable angles for maximizing the anti-leaking property of the properly deployed valve 360. Another benefit, aside from preventing leakage, is reducing or preventing tissue damage at the apex 372.

FIGS. 8-12 illustrate an alignment device according to another embodiment. An alignment device 400 can include some or all of the same or similar features, and can function the same as or similar to, the alignment devices 100, 200 or 300 described above, and can be used to perform the same or similar procedures. The alignment device 400 includes a tube assembly 430, a needle assembly 420 and an imaging probe 440. The tube assembly 430 includes an outer tube member 422 and an imaging element coupling member 424 coupled to a distal end of the outer tube member 422. The needle assembly 420 is movably received at least partially within a lumen defined by the outer tube member 422 and includes a needle tube 426 and an elongate needle 428 (see FIG. 11) that includes a piercing distal tip or stylet 429 and an end cap 456 on a proximal end. The needle assembly 422 also includes a needle coupler 450 that can be used to tighten the needle tube 426 to the elongate needle 428 to control or prevent movement of the elongate needle 428 within the needle tube 426 as desired. For example, the needle coupler 450 can have a threaded attachment such that it can be rotated to tighten or loosen the needle tube 426. The needle coupler 450 can be, for example, a luer type connector. A hemostasis valve 452 is coupled to the outer tube member 422 and can be used to prevent bleeding back through the alignment device 400 during a procedure. The tube assembly 430 includes a luer connector 454 that is coupled to the outer tube member 422 and is configured to control or prevent movement of the needle assembly 420 within the outer tube member 422 as desired. The imaging element coupling member 424 defines a hole 427 (see, e.g., FIG. 12) through which the elongate needle 428 and distal piecing tip 429 of the needle assembly 422 can pass and exit the distal end of the alignment device 400.

The imaging probe 430 includes a cable 432 coupled to a handle assembly 436, and an imaging element 434 (e.g., one or more transducers) coupled to a distal end portion of the cable 432. The imaging probe 440 can be the same as or similar to the imaging probes 140 and 240 described above. For example, the imaging probe 440 can be a known imaging probe that can be coupled to the tube assembly 430. Similarly, the cable 432, handle assembly 436, and imaging element 434 can each be the same as or similar to, and can provide the same as or similar function as the cable 132, handle assembly 136 and imaging element 134, respectively, described above for previous embodiments. The distal end portion of the cable 432 with the imaging element 434 is coupled to the imaging element coupling member 424 as shown, for example, in FIG. 12. For example, the distal end portion of the cable 432 can be received within a groove 425 defined by the imaging element coupling member 424. A pair of screws 443 or other fasteners can be used to secure the cable 432 and imaging element 434 to the imaging element coupling member 424.

As with the previous embodiments, the cable 432 electrically and operatively couples the imaging element 434 (transducer(s)) to control components (not shown) included in the handle 436. Also as with the previous embodiments, the handle 436 can be operatively coupleable to a computer device (not shown) as described above. For example, the handle 436 includes a connection portion 446 that can be used to electrically couple the imaging probe 440 to a computer device.

As described above for alignment devices 100 and 200, alignment device 400 can be used during a procedure to deploy a prosthetic heart device, such as, a prosthetic mitral valve. In use, the imaging element coupling member 424 is placed near or in contact with the epicardial surface of the heart. The imaging element 434 of the imaging probe 440 can then be used to image the heart such that the image data collected can be used to determine an initial desired location to secure a tether attached to the prosthetic mitral valve at the epicardial surface with an epicardial pad, and the C-C plane/axis and the A-P plane/axis can be identified. For example, the image data can be displayed on a display device of the computer device and the C-C plane and A-P plane can be viewed by a user. After the alignment device 400 has been used to obtain the desired image data, and the location for the epicardial pad and the coordinates for the C-C plane and the A-P plane have been determined, the needle assembly 420 can be moved distally within the outer tube member 422 such that the distal piercing tip of the elongate needle pierces through the epicardial surface and extends within the left ventricle of the heart. For example, the distal tip of the elongate needle can be disposed distal of the needle tube 426 such that as the needle assembly 420 is moved distally through the outer tube member 422, the distal tip can pierce the epicardial surface and pass through the wall of the heart. The elongate needle can then be removed leaving the needle tube 426 within the heart and extended within the left ventricle to the native mitral valve. A guidewire (not shown) can then be inserted through the needle tube 426 and positioned within the heart. The guidewire can be advanced through the atrium and anchored to a suitable location within the heart, such as, for example, to the pulmonary vessel area. A balloon can be used in conjunction with the guidewire to avoid having the guidewire interfere with the chordae tendineae, which are found in the ventricle below the mitral valve. The needle tube 426 can then be removed from the heart, and the alignment device 400 removed from the patient's body. A prosthetic mitral valve can then be deployed within the atrium using a prosthetic valve delivery device as described in more detail below. The identified C-C plane and A-P plane can then be used to position and align the prosthetic mitral valve and to secure a tether coupled to the prosthetic mitral valve to the epicardial surface using an epicardial pad device.

FIG. 13 is a flowchart illustrating a method of deploying and aligning a prosthetic valve within a heart using an alignment device as described herein. At 573, a distal end portion of an alignment device as described herein is positioned near or in contact with an epicardial surface of a heart. At 574, the heart is imaged using an imaging element of the alignment device to identify the C-C plane and A-P plane of the mitral valve and annular region of the heart. At 575, a needle assembly of the alignment device is inserted through the epicardial surface and extended within the left ventricle. At 576, an elongate needle of the alignment device is removed leaving a needle tube disposed within the heart. At 577, a guidewire is inserted into the needle tube and a distal end is positioned or anchored to tissue at or near the C-C plane of the native mitral valve. For example, the guidewire can be anchored to, for example, the pulmonary vessel area. At 578, with the guidewire in position in the heart, the alignment device can be removed. At 579, a prosthetic valve delivery device is inserted over the guidewire and into the atrium of the heart to deploy a prosthetic mitral valve at the mitral annulus. At 580, the prosthetic mitral valve is positioned using the C-C plane and A-P plane coordinates determined by the imaging data produced by the alignment device. At 581, a tether attached to the prosthetic mitral valve is secured at an apical site on the epicardial surface with an epicardial pad.

FIG. 14 is a flowchart illustrating another method of deploying a prosthetic valve using an alignment device as described herein in conjunction with a prosthetic valve delivery device. At 682, the initial epicardial pad location is identified using an alignment device as described herein. At 683, the commissural-commissural (C-C) axis and anterior-posterior (A-P) axis of the mitral valve and annular region are identified. At 684, the proper axis of insertion is identified and the needle assembly is moved distally through the tube assembly (e.g., 130, 230, 430) and through the apical ventricular wall. At 685, the elongate needle of the needle assembly is removed, leaving the needle tube in position within the heart, and a guidewire is inserted through the needle tube and into the ventricle, and extended to the atrium. A balloon can optionally be used to avoid having the guidewire interfere with the chordae tendinae, which are found in the ventricle below the mitral valve. At 686, the guidewire is extended up through the atrium and anchored to a suitable location such as the pulmonary vessel area, and the balloon is removed. A dilator can be inserted onto the wire and into the ventricle. At 687, purse string sutures can be attached to the identified apical access site on the epicardial surface. At 688, a catheter (e.g., valve delivery device) is inserted into the atrium. The catheter is loaded with a prosthetic valve, such as a self-expanding tethered cuffed valve described herein. At 689, the compressed (compressed within the catheter or delivery capsule) self-expanding asymmetric transcatheter valve is deployed into the mitral annulus. At 690, an echoradiography or other suitable imaging technique can be used to position the asymmetric valve using the C-C and A-P axis coordinates, which can ensure that the flat(ter) portion of the valve cuff is oriented towards the A2 leaflet and any anti-leakage cuff features are placed within the commissures. At 691, the deployment device catheter and the guidewire can be removed. The tether that is attached to the prosthetic valve can provide a longitudinal sealing force towards the apex, and the tether can be secured to an epicardial pad device at the apical site. In some embodiments, a vacuum low pressure may be applied to provide a temporary positioning seal to affix the probe against the epicardial surface and maintain a correct location once the correct epicardial location is identified under radiography

FIG. 15 is a schematic illustration of a kit according to an embodiment. In some embodiments, a surgical kit 792 can include an alignment device 700 which can be, for example, an alignment device as described herein (e.g., alignment device 100, 200, 400) and a transcatheter prosthetic valve delivery device 793 both disposed within a sterile package 794. In some embodiments, the kit 792 can further include a transcatheter valve 760 (e.g., a prosthetic mitral valve) and/or an epicardial pad 764 that can be used to secure the transcatheter valve 760 in position within the heart. The kit 792 can also include other optional components such as, for example, a guidewire and/or a dilator device (each not shown in FIG. 15).

An epicardial pad device (also referred to as “pad” or “pad device”) as described herein may be a common pledget or similar device, or can be a device having multiple sub-components. In one embodiment, the epicardial pad device may include a flexible pad for contact with the epicardial surface, a sleeve gasket, and a rigid suturing disk as described, for example, in PCT application '049218 incorporated by reference above. Such a flexible pad is intended for contacting the epicardial surface and may be constructed of any suitable biocompatible surgical material. The pad functions to assist sealing of the surgical puncture. In some embodiments, the pad device can be made at least in part of a double velour material to promote ingrowth of the pad into the puncture site area. Pads, or felt pledgets, are commonly made of a felted polyester and may be cut to any suitable size or shape, such as those available from Bard (R) as PTFE Felt Pledgets having a nominal thickness of 2.87 mm. In some embodiments, the pad is larger in diameter than the rigid suturing disk (as described in PCT application '049218.

The sleeve gasket can function to seal any gap or leakage that may occur between the pad and the suturing disk. The sleeve gasket is made of a flexible material so that it can be compressed when the disk and/or pad are tightened against the puncture site, e.g. against the ventricular wall. The sleeve gasket may be connected to the pad and the disk as an integral assemblage, or the components may be separately slid onto the suturing tether, in order, and then tightened against the puncture site, e.g. ventricular wall. The sleeve gasket can function to prevent hemodynamic leakage that may flow along the path of the axially located suturing tether. Such anchoring tethers are used in deployment of prosthetic heart valves and typically extend from within the lumen of the organ being anchored, e.g. the heart, to the external anchoring location, e.g. the epicardial surface. Such epicardial pads may also be used to anchor one or more suturing tethers in other surgical situations where such tether(s) is required to extend from an intraluminal cavity to an external anchoring site.

The rigid suturing disk can function to provide the anchoring and mounting platform to which one or more suturing tethers may be tied. The disk may be made of any suitable biocompatible material. In some embodiments, the disk is made of polyethylene, or other hard or semi-hard polymer, and is covered with a polyester velour to promote ingrowth. In other embodiments, it is made of metal such as Nitinol (R), or ceramic materials. The disk can range in size depending on the particular need. In some embodiments, the size of the disk can range from 1.0-3.0 cm in diameter. In other embodiments, the size of the disk ranges from 0.2-5.0 cm; the larger size not necessarily for intraventricular anchoring but for other surgical use, e.g. hernia repair, gastrointestinal repairs, etc.

One benefit of using a disk as described above to capture and anchor a suture is that, unlike suture anchors that bore into tissue with screws or barbs, there is little or no trauma to the tissue at the site of the anchor. Further, using a disk, which quickly slides over the tether, instead of stitches, allows for the effective permanent closure of large punctures. Surgically closing large punctures by sewing takes time and is difficult. When closing a puncture in the heart, adding the difficulty of requiring a surgeon to sew the puncture closed can increase the likelihood of life threatening complications to the patient. This is especially so in situations where a prosthetic heart valve is delivered and deployed without opening the chest cavity using transcatheter technologies. Sewing a ventricular puncture closed in this situation is typically not tenable.

The disk may also have a channel on its sidewall to allow the tether to be wound around the disk to improve anchoring. This radial channel functions to allow a user to quickly capture and seat a suture tether that is intended to be anchored. A winding channel allows a user to quickly wind suture tether(s) around the disk. Using the winding channel in conjunction with the radial channel(s) allows a user to quickly anchor the suture, while permitting the user to unwind and recalibrate so that the tether tension is appropriate for the particular situation. In some embodiments, a suture that anchors a transcatheter valve will have about 2 lbs. of longitudinal force.

In one embodiment, the tether extends through the flexible pad, sleeve gasket, and rigid suturing disk, and the pad device is applied to the puncture site and makes contact with the epicardial surface. The tether may be trimmed after it is affixed to the disk. In another embodiment, the pad device has a locking pin. The locking pin functions to hold the suturing tether in place after the disk is tightened against the ventricular wall by piercing the tether as it travels axially through the disk. A locking pin hole on the disk allows the locking pin to laterally intersect and affix the longitudinally disposed suturing tether. In another embodiment, the anti-leakage sleeve is unnecessary and not included. In yet another embodiment, the flexible pad is unnecessary and not included. In another embodiment, the suturing disk may have an axial tunnel or aperture which is tapered to allow the suture to be easily threaded into the axial tunnel and to reduce lateral cutting force of the disk against the suture.

While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above

Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components, and/or features of the different embodiments described. 

What is claimed is:
 1. A method, comprising: positioning an alignment device near an epicardial surface of a heart of a patient such that an imaging element mounting member of the alignment device is disposed in contact with the epicardial surface of the heart, the alignment device including a tube assembly including an outer tube member and a coupling member, and a needle assembly movably disposed at least partially within a lumen of the outer tube member, the needle assembly including a needle tube and an elongate needle movably disposed within the needle tube; actuating the alignment device to image the heart with an imaging element coupled to the imaging element mounting member, the imaging producing image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of a mitral valve and an annular region of the heart; determining an insertion point on the epicardial surface for the needle assembly; inserting a distal end portion of the needle assembly through the epicardial surface at the insertion point and into a left ventricle of the heart; removing the elongate needle of the needle assembly leaving the needle tube in position within the heart; inserting a prosthetic valve delivery device through an opening in the epicardial surface and deploying a prosthetic mitral valve within the heart, the prosthetic mitral valve having a tether coupled to the prosthetic mitral valve that extends outside the epicardial surface after being deployed; positioning the prosthetic mitral valve within the heart based at least in part on the C-C plane and the A-P plane determined by the imaging data produced by the alignment device; and securing an epicardial pad to the tether at a location on the epicardial surface.
 2. The method of claim 1, further comprising: after the removing the elongate needle, inserting a guidewire through the needle tube and into a left atrium of the heart; and removing the needle tube.
 3. The method of claim 2, further comprising: prior to inserting the prosthetic valve delivery device, inserting a dilator over the guidewire and into the left ventricle, the dilator configured to provide a lead-in for the prosthetic mitral valve delivery device.
 4. The method of claim 1, further comprising: after the removing the elongate needle, inserting a guidewire through the needle tube and into a left atrium of the heart; anchoring the guidewire to a vessel within the heart; removing the needle tube from the heart; and removing the alignment device from the patient.
 5. The method of claim 1, wherein the imaging the heart includes positioning the imaging element in a first orientation such that image data associated with the location of the C-C plane is produced, and rotating the imaging element about 90 degrees to position the imaging element in a second orientation such that image data associated with the location of the A-P plane is produced.
 6. The method of claim 1, further comprising: determining based at least in part on the image data, an alignment path for inserting the needle assembly into the heart.
 7. The method of claim 1, further comprising: prior to inserting the prosthetic valve delivery device, attaching purse string sutures at the epicardial surface; removing the prosthetic delivery device from the heart; and after the removing the prosthetic delivery device, tightening the purse string sutures to close the opening at the epicardial surface of the heart.
 8. The method of claim 1, wherein the imaging element includes at least one ultrasound transducer.
 9. The method of claim 1, wherein the imaging element includes a side-looking multi-element phased array transducer.
 10. The method of claim 9, wherein the phased-array transducer is configured to operate at a frequency ranging from about 5.0 to about 8.5 MHz.
 11. The method of claim 9, wherein the phased-array transducer is configured to provide at least one of greyscale imaging, color doppler imaging, tissue imaging, or 3D localization.
 12. The method of claim 1, wherein the alignment device is configured to provide multi-direction steerability.
 13. The method of claim 1, further comprising forming a targeting loop with a cable of the alignment device, and contacting a portion of the epicardial surface with the targeting loop to help stabilize the needle assembly when inserted into the heart. 